Intuitive Surgical, Inc. recalls Ion Endoluminal System, REF: 380748-65
There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.
Read the official notice →- Date
- 2024-09-04
- Country
- United States
- Brand
- Intuitive Surgical
- Product
- Ion Endoluminal System, REF: 380748-65
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AZ and CA.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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